Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390774
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-08
Brief Title:
A Study to Evaluate the Safety Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
Sponsor:
Sunshine Guojian Pharmaceutical Shanghai Co Ltd
Organization:
Sunshine Guojian Pharmaceutical Shanghai Co Ltd
Study Overview
Official Title:
A Phase I Clinical Study to Evaluate the Safety Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was an open-label phase I study to evaluate the safety tolerability PK profile and potential efficacy of SSGJ-705 as a single agent in patients with advanced malignancies
Detailed Description:
This study includes 4 Parts Part 1 dose escalation and dose extension for QW administration Part 2 dose escalation and dose extension for Q2W administration Part 3 dose escalation and dose extension for Q3W administration and Part 4 indication extension such as HER2 expression PD-L1 high expression driver gene negative newly treated advanced NSCLC or other tumors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None